Acetaminophen Prescription Combination Drug Products Warning

FDA is recommending health care professionals discontinue prescribing and dispensing
prescription combination drug products that contain more than 325 milligrams (mg) of
acetaminophen per tablet, capsule or other dosage unit. There are no available data to show
that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit
that outweighs the added risks for liver injury. Further, limiting the amount of
acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent
acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Cases of severe liver injury with acetaminophen have occurred in patients who:

took more than the prescribed dose of an acetaminophen-containing product in a 24-hour
period;

took more than one acetaminophen-containing product at the same time; or

drank alcohol while taking acetaminophen products.

In January 2011 FDA asked manufacturers of prescription combination drug products
containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each
tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from
the risk of severe liver damage which can result from taking too much acetaminophen. This
category of prescription drugs combines acetaminophen with another ingredient intended to
treat pain (most often an opioid), and these products are commonly prescribed to consumers
for pain, such as pain from acute injuries, post-operative pain, or pain following dental
procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication,
and is often combined with other ingredients, such as cough and cold ingredients. FDA will
address OTC acetaminophen products in another regulatory action. Many consumers are often
unaware that many products (both prescription and OTC) contain acetaminophen, making it easy
to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request. However,
some prescription combination drug products containing more than 325 mg of acetaminophen per
dosage unit remain available. In the near future FDA intends to institute proceedings to
withdraw approval of prescription combination drug products containing more than 325 mg of
acetaminophen per dosage unit that remain on the market.

FDA recommends that health care providers consider prescribing combination drug products
that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist
receives a prescription for a combination product with more than 325 mg of acetaminophen per
dosage unit that they contact the prescriber to discuss a product with a lower dose of
acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In
that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage
units). When making individual dosing determinations, health care providers should always
consider the amounts of both the acetaminophen and the opioid components in the prescription
combination drug product.